Developing the Corporate CMC Regulatory Compliance Strategy

  • John Geigert


‘We have to move fast because the competition is on our tail; we have limited funds and staff to move our biopharmaceutical through clinical development so we cannot do everything and hire everybody we want; so what CMC must we absolutely have to do now to be successful, and what can we do at a later stage of clinical development?’


Drug Product Drug Substance Biopharmaceutical Product Regulatory Submission Biopharmaceutical Company 
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Copyright information

© Springer Science+Business Media New York 2004

Authors and Affiliations

  • John Geigert
    • 1
  1. 1.BioPharmaceutical Quality SolutionsCarlsbadUSA

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